MOP · Class I · 21 CFR 870.3935

FDA Product Code MOP: Rotator, Prosthetic Heart Valve

Leading manufacturers include Carbomedics, Inc., Sulzer Carbomedics, Inc. and Genzyme Surgical Product (Genzyme Biosurgery).

4
Total
4
Cleared
148d
Avg days
1995
Since

FDA 510(k) Cleared Rotator, Prosthetic Heart Valve Devices (Product Code MOP)

4 devices
1–4 of 4
Cleared Aug 07, 1998
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
K980016
Genzyme Surgical Product (Genzyme Biosurgery)
Cardiovascular · 217d
Cleared Aug 04, 1998
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
K974648
Sulzer Carbomedics, Inc.
Cardiovascular · 235d
Cleared Apr 29, 1996
CARBOMEDICS MITRAL ROTATOR
K960923
Carbomedics, Inc.
Cardiovascular · 54d
Cleared Jun 20, 1995
CARBOMEDICS EXENDED MITRAL ROTATOR
K951368
Carbomedics, Inc.
Cardiovascular · 85d

About Product Code MOP - Regulatory Context